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PMA P080023S034

Device
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit
Applicant
Abbott Laboratories
PMA number
P080023
Supplement
S034
Product code
LOM
Decision date
2021-04-22
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH).

Current openFDA PMA Record#

Device
ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit
Applicant
Abbott Laboratories
PMA number
P080023
Supplement
S034
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2021-04-22
Decision code
APPR
Date received
2021-02-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH).